Surgical helical fastener with applicator

ABSTRACT

A helical fastener having a high retentive surface area is provided and has a first end for enhancing penetration into tissue and a second end comprising a coil sectioning a diameter of the fastener for receiving longitudinal and rotational forces. The helical fasteners are attached to body tissue by a fastener applicator having a proximal portion comprising a handle and an actuator and an elongate distal portion for housing a plurality of fasteners. A transferring action of the actuator provides longitudinal and rotational movement of the fasteners out of the distal portion and into body tissue.

BACKGROUND OF THE INVENTION

[0001] This invention relates to surgical fasteners and their associatedapplicators, and more particularly, surgically fastening material totissue.

[0002] Fasteners have been used surgically to eliminate the need forsuturing, which is both time consuming and inconvenient. In manyapplications the surgeon can use a stapler apparatus, i.e., a fastenerimplanting device loaded with surgical fasteners to accomplish in a fewseconds what would have taken many minutes to perform by suturing. Thisreduces blood loss and trauma to the patient.

[0003] Conventional surgical fasteners have been in the form of ordinarymetal staples, which are bent by the delivery apparatus to hook togetherbody tissue. Typically, conventional staples comprise a pair of legsjoined together at one end by a crown. The crown may be a straightmember connecting the legs or may form an apex. Moreover, the legs mayextend substantially perpendicular from the crown or at some angletherefrom. Irrespective of the particular configuration, however,conventional staples are designed so that they may be deformed to holdbody tissue.

[0004] Accordingly, the stapler applicators have conventionally embodiedstructure functioning to project the conventional staple into tissue aswell as to deform the staple so that it is retained against the tissue.Generally speaking, typical applicators include an anvil cooperatingwith means to eject the conventional staple from the applicator. In someapplications, access to the body tissue from two opposite directions isavailable and the anvil can operate to deform the legs of the stapleafter they have passed through the body tissue. In applications whereaccess to the tissue is from only one direction, the anvil may deformthe crown of the conventional staple so that its legs will project intothe body tissue in a fashion so as to hold the staple against thetissue.

[0005] Since conventional staples require deformation and must cooperatewith applicators having an anvil or other means to deform the staples,conventional applicators typically comprise complex structures and canbe prohibitively expensive. Conventional applicators must embodystructure functioning to not only eject the fasteners but to do so in amanner so that the fastener deforms properly and timely.

[0006] In some applications, conventional applicators must be equippedwith structure functioning to move the anvil into and out of position sothat when the fastener is ejected from the applicator, the anvil isproperly positioned and once fastener deformation is complete, moves outof position, thereby allowing the process to be repeated. Moreover, theanvil must be formed into a proper configuration so that fastenerdeformation can be repeated accurately. Further, the force between thefastener and the anvil must be controlled so that repeated deformationis accomplished. The objectives of many inventions in this field havebeen to accomplish these goals by the simple manipulation of a singlelever. It is to be appreciated, therefore, that the fastener applicatorshave become complex and expensive instruments.

[0007] Two part fasteners have also been conventionally utilized, wherea barbed staple is used in conjunction with a retaining piece to holdthe staple in place. Typically, the two part staple comprises a crown orbackspan and two barbed prongs which are engaged and locked into aseparate retainer piece. In use, the staple is pressed into the bodytissue so that the barbs penetrate the tissue and emerge from the otherside where they are then locked into the retainer piece. Retainersprevent the staple from working loose from the tissue. The two piecefasteners cannot be unlocked and are not removable.

[0008] Like other conventional applications, however, the two piecefasteners require the staple delivery apparatus to have access to bothsides of the tissue. Thus, as with the other conventional applications,two piece fasteners are limited since they cannot be used where accessto tissue is from one direction only.

[0009] In those situations where access to body tissues is limited toone direction, as in grafting procedures, deformable surgical fastenershave been conventionally employed. As mentioned previously, however; theapplicators commonly used in these situations embody an anvilcooperating with a fastener to deform it and consequently, tend to be ofa complex design.

[0010] Some advancements have been made in this area so that applicatorsfunctioning to attach grafts to tissue, for instance, are not requiredto embody an anvil and may, therefore, have a more simple design. Inparticular, it has been suggested in the art to employ fasteners withbarbs, thereby eliminating the need for deforming the fastener. Thesefasteners are limited, however, since the path created in the graft andtissue by the barbs as the fastener is pressed into the graft and tissuemay allow the fastener to loosen its grip or to entirely back out ofengagement. Moreover, due to their sole reliance upon barbs to retaintissue, the barb fasteners are further limited in that they may not havea great enough retentive surface area for securely holding tissue inplace.

[0011] To circumvent or overcome the problems and limitations associatedwith conventional fasteners and applicators, a simple applicator thatdispenses a surgical fastener having high surface area for retentivecontact with tissue and that can be delivered into body tissue from onedirection may be employed. The present invention embodies thesecharacteristics.

SUMMARY OF THE INVENTION

[0012] The invention includes a surgical fastener and an applicator usedin delivering the fastener into body tissue. The fastener and applicatorof the present invention may be used in a number of medical proceduresincluding ligating tissue, hernia mesh repair, bladder neck suspension,and in conjunction with implant drug delivery systems or proceduresinvolving positioning of surgical or implantable devices in a patient'sbody.

[0013] The preferred embodiment of the surgical fastener of the presentinvention is formed into the configuration of a continuous helical coil.The continuous helical coil is longitudinally collapsible andexpandable. At the distal end of the helical fastener is a point forenhancing penetration into tissue. The proximal end of the helicalfastener has a T-bar which sections the diameter of the fastener,thereby providing a surface for receiving and transmitting longitudinaland rotational forces so that the fastener may be driven into tissue bya corkscrew action. The pitch and length of the helical fastener mayvary upon the application as can its diameter and configuration of themost proximal and distal coils comprising the fastener. Additionally,the material selection and fastener stiffness may be selected with aparticular application in mind.

[0014] In another embodiment of the surgical fastener, the fastenercomprises a double continuous helical coil that is also longitudinallycollapsible and expandable and may embody various configurationsdepending upon the application. Moreover, the distal end of the doublehelical fastener comprises two points for enhancing penetration intotissue and its proximal end comprises a connector bar which connects thetwo helixes as well as sections the diameter of the double helicalfastener. In yet another embodiment, the surgical fastener furthercomprises a pivot post extending through the center of the fastener andoperating to provide the fastener with a stable pivot. In any of theembodiments, one or more barbs may be employed near the point to enhanceanchoring characteristics.

[0015] A preferred embodiment of the fastener applicator of the presentinvention includes a proximal portion and a distal portion. The proximalportion is preferably fabricated to be a “reusable” component and thedistal portion a “disposable” component. Alternatively, both the distaland proximal portion can be made disposable. The distal portion iselongate and embodies an outer tube housing an inner rotator, a lockclip/indicator and a load spring. The proximal portion includes ahandle. In the preferred embodiment of the distal portion, a thread formcomprising an interlock spring is provided within the outer tube. Therotator includes a structure running longitudinally along its lengththat functions to receive the T-bar or connector bar of the fastener andin this way, the rotator may hold a plurality of fasteners. The loadspring applies a force against the lock clip/indicator operating to biasthe plurality of springs distally within the outer tube and towards thenose piece. The thread form functions to engage the coils of the helicalfasteners and when rotating the rotator, a fastener is driven from thedistal end of the applicator. In other embodiments of the applicator,the distal end has various other structures functioning to engage thecoils of the fastener and to drive them from the distal end of theapplicator. In one other embodiment, the distal end comprises a nosepiece protrusion for engaging the fastener.

[0016] In order to cause the rotator to rotate, the proximal portion ofthe applicator has a handle and an actuator cooperating with therotator. In a preferred embodiment, the proximal portion of theapplicator embodies a lever pivotally attached about a midpoint to thehandle. A first end of the lever is configured to be gripped by hand anda second-end is adapted to engage a nut driver. The nut driver travelsalong a helical lead screw which is connected to the rotator. When thelever is squeezed by hand the nut driver travels along the lead screwcausing it to rotate, and through the connection of the lead screw tothe rotator, the action of the lead screw causes the rotator to rotate.

[0017] Further, the lever comprises a midsection extension. Pivotallyattached to the midsection extension of the lever is a spring loadedpawl adapted to releasably engage gear teeth formed in the interior ofthe handle. The spring loaded pawl prohibits the lever from backstrokinguntil it has been completely depressed. Upon complete depression of thelever, the pawl clears the gear teeth and the spring, biasing the pawl,rotates the pawl away from the teeth, thereby allowing the lever toreturn to its undepressed condition.

[0018] In another embodiment of the proximal portion of the applicator,the lever is pivotally attached at a first end to the handle, the secondend being adapted to engage the nut driver. Further, rather thanembodying a spring loaded pawl, this alternate embodiment of theproximal portion includes a clutch assembly or releasable connectionbetween the lead screw and rotator and cooperating means to prohibit thelever from backstroking until it has been completely depressed.

[0019] Other features and advantages of the present invention willbecome apparent from the following detailed description, taken inconjunction with the accompanying drawings, which illustrate, by way ofexample, the principals of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020]FIG. 1 depicts a perspective view of a fastener of the presentinvention, illustrating a side view of a helical fastener.

[0021]FIG. 1A depicts another perspective view of the fastener of thepresent invention, illustrating an end view of the helical fastener.

[0022]FIG. 1B depicts a schematic view of a fastener of the presentinvention, illustrating a substantially collapsed helical fastener witha relatively small gap that has been partially inserted into tissue.

[0023]FIG. 1C depicts a schematic view of a fastener of the presentinvention, illustrating the helical fastener depicted in FIG. 1Bcompletely inserted into tissue.

[0024]FIG. 1D depicts a schematic view of a fastener of the presentinvention, illustrating a substantially collapsed helical fastener witha relatively large gap that has been partially inserted into the tissue.

[0025]FIG. 1E depicts a schematic view of a fastener of the presentinvention, illustrating the helical fastener depicted in FIG. 1Dcompletely inserted into tissue.

[0026]FIG. 1F depicts a perspective view of another embodiment of thepresent invention, illustrating an end view of the helical fastener.

[0027]FIG. 2 depicts a perspective view of another embodiment of thepresent invention, illustrating a double helical fastener.

[0028]FIG. 2A is a front view of the double helical fastener of FIG. 2.

[0029]FIG. 2B is side view of the double helical fastener of FIG. 2.

[0030]FIG. 2C is a top view of the double helical fastener of FIG. 2.

[0031]FIG. 3 is a perspective view of yet another embodiment of thepresent invention, illustrating another design of a double helicalfastener.

[0032]FIG. 3A is a front view of the double helical fastener of FIG. 3.

[0033]FIG. 3B is a side view of the double helical fastener of FIG. 3.

[0034]FIG. 3C is a top view of the double helical fastener of FIG. 3.

[0035]FIG. 4 is a perspective view of the present invention,illustrating a helical fastener with a central post.

[0036]FIG. 5 depicts a schematic cross-sectional view of an applicatorof the present invention, illustrating a side view of the applicator.

[0037]FIG. 6 is a schematic cross-sectional side view of a terminal endof the applicator.

[0038]FIG. 6A is a schematic cross-sectional end view of a terminal endof the applicator.

[0039]FIG. 7 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating the preferred embodiment of the terminalend.

[0040]FIG. 7A is a schematic cross-sectional end view of the preferredembodiment of the terminal end of the application shown in FIG. 7.

[0041]FIG. 8 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating another embodiment of the terminal end.

[0042]FIG. 8A is a schematic cross-sectional end view of the embodimentof the terminal end of the applicator shown in FIG. 8.

[0043]FIG. 9 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating yet another embodiment of the terminal end.

[0044]FIG. 9A is a schematic cross-sectional end view of the embodimentof the terminal end of the applicator shown in FIG. 9.

[0045]FIG. 10 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating still yet another embodiment of theterminal end.

[0046]FIG. 10A is a schematic cross-sectional end view of the embodimentof the terminal end of the applicator shown in FIG. 10.

[0047]FIG. 11 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating another embodiment of the terminal end.

[0048]FIG. 11A is a schematic cross-sectional end view of the embodimentof the terminal end of the applicator shown in FIG. 11.

[0049]FIG. 12 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating a further embodiment of the terminal end.

[0050]FIG. 12A is a schematic cross-sectional end view of the embodimentof the terminal end of the applicator shown in FIG. 12.

[0051]FIG. 13 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating a still further embodiment of the terminalend.

[0052]FIG. 14 is a schematic cross-sectional view of the terminal end ofthe applicator, illustrating still yet another embodiment of theterminal end.

[0053]FIG. 15 is a schematic cross-sectional view of another applicatorof the present invention, illustrating a side view of the applicator.

[0054]FIG. 16 is a schematic partial cross-sectional view of areleasable connection between the lead screw and rotator.

[0055]FIG. 16A is schematic representation of a distal end of the leadscrew, illustrating an end view of the lead screw.

[0056]FIG. 16B is a schematic representation of the distal end of thelead screw, illustrating a side view of the lead screw depicted in FIG.16.

[0057]FIG. 16C is a schematic representation of the proximal end of therotator, illustrating a side view of the rotator.

[0058]FIG. 16D is a schematic representation of the proximal end of therotator, illustrating an end view of the rotator depicted in FIG. 16B.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] As is shown in the drawings, which are included for purposes ofillustration and not by way of limitation, the invention is embodied ina continuous helical fastener and an applicator therefor. The helicalfastener has a high retentive surface area and the applicator has asimple design and functions to dispense the helical fasteners, withoutsubstantially deforming the fasteners, into body tissue, access to whichis from one direction only. Some conventional fasteners requiredeformation to hold tissue and are consequently limited sine theyrequire complex applicators to attach them into tissue. Otherconventional fasteners lack high retentive surface area for securelyholding tissue. Still other fastener/applicator systems require accessto tissue from two directions in order to accomplish attaching afastener to tissue. Thus, the helical fastener and applicator of thepresent invention provides a superior means to attach fasteners totissue.

[0060] One embodiment of the present invention (FIGS. 1, 1A and 5) isembodied in a helical fastener 10 which is attached to tissue byemploying a novel applicator 12 which rotates the fastener 10 intotissue. The dimensions and physical characteristics of the helicalfastener 10 are selected to insure a secure attachment of the fastener10 to tissue. Similarly, the dimensions and physical characteristics ofthe applicator 12 utilized to dispense the fasteners 10 into tissue aredependent upon the application.

[0061] In a preferred embodiment, the fastener 10 is formed into theconfiguration of a continuous helix and may have a depth 16, a diameter18 and a pitch 20 determined by the application. The continuous helixmay be longitudinally collapsible and expandable. The cross-sectionalprofile of the continuous helix is substantially circular in thepreferred embodiment but can be square, rectangular or triangular. In aparticular application such as mesh anchoring for hernia repair, thepre-formed pitch can be 0.050 inches. However, the preformed pitch canvary from 0 to a maximum of approximately 3.0 times the coil diameter.In other embodiments, it is contemplated that the pitch 20 vary alongthe length of the fastener 10 so as to optimize the retaining force ofthe fastener 10. Moreover, since the continuous helical coil ispreferably longitudinally collapsible and expandable, upon insertioninto tissue, the final pitch 31 may be less than or greater than thepre-formed pitch. If the coil is made of rigid construction, as is alsocontemplated, pitch would be made substantially fixed. The diameter inthe preferred embodiment may be 5 mm; however, designs ranging from 1 mmand up are contemplated. In practice, the depth 16 of the fastener 10must be selected so that the extent of fastener penetration into tissueis sufficient to hold the fastener 10 in place.

[0062] Moreover, distal end 22 of the fastener 10 is to be configuredsuch that a gap 23 exists between the most distal coil 27 (or firstcoil) of the fastener 10 and its adjacent coil. As may be appreciatedfrom the preferred embodiment of FIGS. 1B through 1E, as the fastener 10is pressed against tissue 25, all of the coils substantially collapseexcept the most distal coil 27, leaving the gap 23 to determine the paththe fastener 10 takes as it is rotated into the tissue 25 and moreimportantly, the extent of penetration 29 into the tissue 25 and finalpitch 31 of the fastener 10 in tissue. Although FIG. 1B showssubstantially all of the coils being collapsed, it is to be appreciatedthat, depending upon the applicator utilized to implant the fastener 10,fewer coils than all of the coils may be collapsed at any one time. Itremains, however, that since the fastener 10 is longitudinallycollapsible and expandable, it is the gap 23 that generally determinesfinal pitch 31. Accordingly, the magnitude of the gap 23 can be varied,depending upon the application, to achieve the desired final pitch 31and penetration 29 in tissue. Thus, the greater the gap 23, uponinsertion of the fastener 10 in tissue, the greater the penetration 29and final pitch 31 of the fastener 10 in tissue.

[0063] In the preferred embodiment, the distal end 22 of the helicalfastener 10 terminates with a point 24. The point 24 may be sharp orblunt depending upon the tissue to which the fastener 10 will beaffixed. Additionally, one or more barbs or a sharp point projecting inreverse direction to point 24 (not shown) can be added to fastener 10near point 24 to enhance anchoring characteristics of the fastener. Aproximal end 26 of the helical fastener 10 may comprise structurefunctioning to receive and transmit applied longitudinal forces. In thepreferred embodiment, th most proximal coil is formed into a T-bar 33that perpendicularly sections the diameter 18 of the fastener 10. Inalternate embodiments, it is also contemplated that the most proximalcoil section the diameter 18 non-perpendicularly or be formed into aspiral 35 existing in a single plane (See FIG. 1F).

[0064] Concerning the material of the helical fastener 10, it iscontemplated in the preferred embodiment that the fastener be made fromsemi-stiff implantable wire, such as titanium, wound into a helicalshape. In alternate embodiments, the helical fastener 10 may compriseplastic or absorbable materials. Examples of materials that can be usedin constructing the helical fastener 10 include titanium, titaniumalloys, stainless steel, nickel, chrome alloys and any otherbiocompatible implantable metals. Other options for materials are liquidcrystal polymers, HDPE, polyglycolic acid, and polyglycolidhydroxgacetic acid. Further, it may also be desirable to coat thefastener, or a portion thereof, with a biocompatible lubricious materialthat provides for easier delivery of the fastener into tissue.

[0065] In another embodiment of the surgical fastener, the fastener 110is formed into the configuration of a double helix (See FIGS. 2-2C). Byembodying a double helix, the fastener 110 has increased retentivestrength as well as means to balance the fastener 110 as it is pressedinto tissue. As with the helical fastener 10, the configuration of thedouble helical fastener 110, i.e., the pre-formed pitch and diameter,may be varied for a particular application and a barb may be employed toenhance anchoring in tissue. Moreover, the materials contemplated arethe same as those for the helical fasteners. Further, the double helicalfastener 110 is also longitudinally collapsible and expandable and itsfinal pitch is dependent upon the gap 112 existing between the mostdistal coils 114, 115 of the fastener 110 and their adjacent coils.

[0066] Regarding the proximal 118 and distal 120 ends of the doublehelical fastener 110, they compris structure to drive the fastener intotissue as well as tissue piercing structures. The proximal end 118 has aconnector bar 122 sectioning the diameter of the fastener that connectsone helical coil to another and functions to receive and transmitlongitudinal forces. The distal end 120 terminates with two points 124,125 for piercing and facilitating the implantation of the fastener 110into tissue.

[0067] As may be appreciated by comparing FIGS. 2-2D with FIGS. 3-3D, itis contemplated that the double helical fastener 110 have a full turndesign (FIGS. 2-2D) as well as a half turn design (FIGS. 3-3D). It is tobe understood, however, that the designs having more than one turn andhaving other increments of turns are contemplated. It is the applicatorthat will determine the required number of turns for a specific fastener110.

[0068] In yet another embodiment of the surgical fastener, as shown inFIG. 4, the double helical fastener 110 is provided with a pivot post130 having a pointed terminal end 132. The pivot post 130 of thisembodiment operates to provide the fastener 110 with a stabilizingelement so that, as the fastener 110 is being turned, the helical coilscooperatively enter the tissue.

[0069] The applicator 12 (FIG. 5) comprises a proximal portion 28 havinga handle 30 and an actuator 32 and a cooperating elongated distalportion or cannula 34 housing a plurality of fasteners. In general,through the manipulation of the actuator 32, the fasteners are ejected,one by one, out of a distal portion 34 and into body tissue. Theapplicator 12, hereinafter described in more detail, is equallyproficient in driving each of the embodiments of fasteners set forthabove into tissue.

[0070] In more detail (see FIGS. 6 and 6A), the distal portion 34comprises an outer tube 36 housing a rotator 38, a lock/clip indicator40 and a load spring 42. Extending longitudinally along the rotator 38is a groove 44 which operates to receive the most proximal coilsectioning the fastener. Although FIG. 6 shows only a single fastener(having a single helical design) retained by the rotator 38, it is to beappreciated that the rotator 38 may receive a plurality of fasteners(having a single or double helical design), wherein each fastener hasits last coil positioned within the rotator groove 44. Moreover,although not depicted in FIG. 3, it is also contemplated that ratherthan embodying a groove, the rotator 38 has a cross-sectional profileapproximately a “D”, wherein the flat portion operates to engage thecoil sectioning the fasteners. Irrespective of the configuration of therotator, however, the rotator is to embody structure functioning toengage a plurality of fasteners and to facilitate turning them intotissue.

[0071] It is also to be appreciated that load spring 42 applies a forcethrough the lock clip indicator 40 to bias the plurality of fastenersdistally. The lock clip/indicator 40 may comprise a simple washer sizedand shaped to engage the fasteners and rotator 38 as well as to receiveforces from the load spring 42. Additionally, lock/clip indicator 40serves as a jam stop to prevent further actuation by rotator 38 upondischarge of all fasteners by mating with, or abutting against,structure comprising the terminal end 50 and preventing furtherrotation. Lock/indicator 40 can be made of a color (or shape) to serveas an empty indicator notifying the user that no more fasteners areavailable other embodiments of the indicator 40 may be utilized as longas they function to transmit forces to bias the fasteners distally. Theload spring 42 is to be retained within the outer tube 36 and to havephysical characteristics such that sufficient forces may be appliedthrough a front end 43 to a last remaining fastener contained within theapplicator 12. A back end (not shown) of the load spring 42 may beplaced against any stationery structure within the outer tube 36,thereby providing a foundation against which the spring 42 may becompressed. In a preferred embodiment, the load spring 42 extendssubstantially the length of the distal portion 34.

[0072] In the preferred embodiment (FIGS. 7 and 7A), the outer tube 36is configured with a thread form 201 comprising an interlock spring 203fixedly retained within the outer tube 36 and extending substantiallythe length thereof. The interlock spring 203 may be fixedly retainedwithin the outer tube 36 by ensuring a tight interference between theparts or the interlock spring may be spot welded or equivalently bondedwithin the outer tube. The thread form 201 operates to guide thefasteners through the distal portion 34 and to eject them from theapplicator 12.

[0073] In another embodiment of the applicator 12 (FIGS. 8 and 8A),attached at a terminal end 46 of the distal portion 34 may be a nosepiece 48. The nose piece 48 may further comprise a protrusion 50extending perpendicularly and towards a longitudinal axis 52 of thedistal portion 34. This nose piece protrusion 50 also functions toengage the surgical fasteners and to force them from the terminal end 46of the distal portion 34 as well as engaging lock/clip indicator 40 asdescribed above.

[0074] In other embodiments of the applicator 12, the distal portionembodies other structure or thread forms functioning to engage thesurgical fasteners and guide them out of the applicator and into tissue(See FIGS. 9-14). In FIGS. 9 and 9A, the outer tube 36 is rolled at itsterminal end 46 and a 180° portion of the rolled terminal end is cutaway. The remaining roll d portion engages the fastener while theportion cut away provides an exit for the fasteners. The embodimentdepicted in FIGS. 10 and 10A is similar to that of FIGS. 9 and 9A, thedifference being that instead of removing a portion of the rolledterminal end 46, it is stamped or deformed to thereby provide an exit.FIGS. 11 and 11A show yet another embodiment, wherein two longitudinallyspaced apart stabilizing points 301, 302 are formed 180° from each otherwithin the outer tube. These stabilizing points also operate to engagethe fastener and guide it into tissue. Turning to FIGS. 12, 12A, 13 and14, they each comprise a terminal end 46 formed with threads whichoperate to engage and eject a fastener. In FIGS. 12 and 12A are depictedthreads machined or formed solely within the inside of the outer tube.FIG. 13 shows an internally threaded sleeve attached to the outside ofthe terminal end 46 of the outer tube 36. FIG. 14 illustrates anapplicator 12 provided with a terminal end 46 deformed so as to haveinternal and external threaded structures. Irrespective of the designchosen for the terminal end of the applicator, however, each of thedesigns are effective with a relatively small overall outer diameter,i.e., on the order of 5 mm.

[0075] In order to eject surgical fasteners from the distal portion 34,the actuator 32 functions to turn the rotator 38. As the rotator turns,the distal end 22 of a fastener is threaded out of the terminal end 46of the applicator 12 (see FIG. 5).

[0076] In the preferred embodiment of the proximal portion 28 of theapplicator 12 (See FIG. 5), a lever 54 is pivotally connected about amidpoint 56 to the handle 30. A first end 58 of the lever 54 is to beconfigured for gripping by hand. A second end 60 of the lever is to beadapted to pivotally engage a nut driver 62.

[0077] The nut driver 62 of the applicator 12 travels upon a high helixlead screw 64 which is rotatably mounted within the proximal portion 28.In the preferred embodiment, a longitudinal axis of the high helix leadscrew 64 is coaxial with the longitudinal axis 52 extending through thedistal portion 34 of the applicator 12. Upon manipulation of the lever54, the nut driver 62 travels along the lead screw 64 causing it torotate through a connection of the lead screw 64 to the rotator 38, theaction of the lead screw causes the rotator to rotate. The lead screw 64may be connected to the rotator 38 by any conventional means. Forinstance, the lead screw 64 can have an internal bore receiving andengaging an end of the rotator 38. Further, the length of travel of thenut driver 62 along the lead screw 64 is chosen such that it causes therotator to rotate a predetermined number of times so that a singlehelical fastener 10 is ejected from the applicator 12.

[0078] Additionally, in the preferred embodiment, the lever furthercomprises a midsection extension 66. Pivotally attached to themidsection extension 66 of the lever 54 is contemplated to be a springloaded pawl 68 adapted to releasably engage gear teeth 70 formed in theinterior of the handle 30. Spring loaded pawl 68 is configured toprohibit the lever 54 from backstroking until it has been completelydepressed. Upon complete depression of the lever 54, the pawl 68 clearsthe gear teeth 70 and the spring biasing the pawl 68 rotates the pawl 68away from the teeth 70, thereby allowing the lever 54 to return to itsundepressed condition.

[0079] In operation, upon complete depression of the lever 54, the nutdriver 62 travels a pre-determined distance along the lead screw 64,causing the rotator 38 to rotate a pre-determined number of revolutionscorresponding to a number of turns of a particular helical fastener 10.As the rotator 38 rotates, the fasteners retained by the rotator alsorotate and the coils of the most distal fastener are threaded out of theterminal end 46 of the applicator 12 and into tissue. Moreover, wherethe lever 54 is only partially depressed, the spring loaded pawl 68operates to hold the lever 54 stationery and will continue to functionto hold the lever 54 stationery until the lever 54 has been completelydepressed. In this way, the delivery of fasteners into body tissue iscontrolled so that only a single fastener may be completely ejected outof the applicator 12 and pressed into body tissue at a time.

[0080] In the preferred embodiment, the proximal portion 28 isfabricated to have a reusable handle that can be re-sterilized, and thedistal portion is made disposable. Thus, upon discharge of all thefasteners 10 from distal portion 34, the distal portion would bediscarded and replaced. The handle could be reused up to a limitednumber of procedures.

[0081] In another embodiment of the proximal portion 328, of theapplicator 312 (FIG. 15), a lever 354 is pivotally connected at a firstend 355 to the handle 330 and biased to its undepressed position by aspring 357. The mid-section 358 of the lower 354 is configured forgripping by hand. A second end 360 of the lever is to be adapted topivotally engage a nut drive 362.

[0082] The nut driver 362 of the applicator 312 travels along a highhelix lead screw 364 which is rotatably mounted within the proximalportion 328. Upon manipulation of the lever 354, the nut driver travelsalong the lead screw 364 causing it to rotate and, through a clutchassembly or a releasable connection of the lead screw 364 to the rotator38, the action of the lead screw causes the rotator to rotate.

[0083] Further, the lever 354, has a mid-section extension 366 thatcooperates with a spring biased latch pawl mechanism 368 fixed to thehandle adapted to releasably engage teeth 370 formed on the mid-sectionextension 366. The spring biased latch pawl is configured to prohibitthe lever 354 from backstroking until it has been completely depressed.Upon complete depression of the lever 354, the latch pawl 368 clears themid-section teeth 370 and the spring biased latch pawl 368 rotates awayfrom the teeth, thereby allowing the lever 354 to return toits-undepressed condition.

[0084] As stated, there is a releasable connection between the leadscrew 364 and the rotator. The releasable connection provides theapplicator with means to disengage the distal portion of the applicatorfrom the proximal portion. In this way, the proximal portion can bere-used with various different designs of the proximal portion. Further,while the lever 354 is being depressed, the clutch assembly orreleasable connection functions to transfer the rotation of the leadscrew 364 to the rotator 38, thereby causing the rotator to rotate.Additionally, upon complete depression of the lever, the clutch assemblyoperates to allow relative motion of the lead screw 364 and the rotator.

[0085] One such releasable connection contemplated is a conventionalratchet mechanism. As shown in FIGS. 16-16D, the distal end 370 of thelead screw 364 has a connecting surface 372 equipped with leaf springs374, 376 each having an engaging face 377 and an internal bore 378existing coaxially with a longitudinal axis of the lead screw. Theproximal end 380 of the rotator 38 has a cooperating connecting surface382 having ridges 384 for releasable engagement with the leaf springs374, 376 and an extension 386 adapted to fit within the internal bore ofthe lead screw connecting surface. As may be appreciated from the FIGS.,as the lead screw turns so that the ridges 384 contact the engagingfaces 377 of the leaf springs 374, 376, the rotation of the lead screw364 will cause the rotator 38 to likewise rotate. Where the lead screwis turned in the opposite direction, the ridges 384 will not engage theengaging face of the leaf springs and the motion of the lead screw 384will not be transferred to the rotator 38.

[0086] In this embodiment, upon complete depression of the lever 354,the nut driver 362 travels a pre-determined distance along the leadscrew 364, causing the rotator 38 to rotate a pre-determined number ofrevolutions. As the rotator 38 rotates, the fasteners retained by therotator also rotate and the coils of the most distal fasteners arethreaded out of the applicator and into the tissue. At this point, thelatch pawl mechanism 368 disengages from the teeth 370 and the lever 354is returned to its undepressed position by spring 357. As with theprevious embodiment of the proximal portion 28, the proximal portion ofthis embodiment functions to allow only a single fastener to becompletely ejected from the applicator and be pressed into body tissueat a time.

[0087] In other embodiments, means to cause the rotator to rotate maycomprise a single knob connected to a rotator which can be turned byhand. Additionally, the revolving means may include a rack and gearstructure or a set of beveled gears. Further, instead of comprising agroove, the rotator may be internally threaded, wherein the threadedportions function to house as well as advance the helical fasteners 10.Irrespective of the means or structure employed, however, it iscontemplated that the number of revolutions of the rotator be set to apre-determined parameter so that the delivery of helical fasteners totissue may be controlled.

[0088] From the foregoing, it will be appreciated that the helicalfastener in applicator of the present invention functions to securelyattach a fastener with high retentive surface area to tissue from onedirection through the utilization of an applicator having a simpledesign. It is also to be appreciated that the present invention may beutilized in a number of applications including ligating tissue, herniamesh repair, bladder neck suspension, and in conjunction with implantdrug delivery systems or procedures involving positioning of surgical orimplantable devices in patient.

[0089] While several particular forms of the invention have beenillustrated and described, it will also be apparent that variousmodifications can be made without departing from the spirit and scope ofthe invention.

[0090] Thus, it should be understood that various changes in form,detail and application of the present invention may be made withoutdeparting from the spirit and scope of this invention.

What is claimed is:
 1. An applicator for attaching fasteners to bodytissue comprising: a distal portion having an elongate outer tube, aconnecting end and a terminal end; a proximal portion having a handleand an actuator, the proximal portion being attached to the connectingend of the distal portion; and a rotator cooperating with the actuatorand including a longitudinal groove extending along at least a portionof the length of the rotator, the groove configured to receive a portiona fastener, wherein the rotator resides within and extends substantiallythe length of the outer tube such that actuation of the actuator rotatesthe fastener relative to the outer tube.